BI836845 Plus Enzalutamide in Castrate Resistant Prostate Cancer (CRPC)
Status:
Active, not recruiting
Trial end date:
2022-02-24
Target enrollment:
Participant gender:
Summary
The overall aim of the trial is to investigate the safety and anti-tumour activity of an
experimental drug BI 836845 taken together with the prostate cancer drug, enzalutamide,
compared to enzalutamide given alone, in castrate resistant prostate cancer (CRPC) patients
that have previously been treated and failed on docetaxel and abiraterone treatments.
Initially, a tolerability and safety phase (phase Ib escalation) will be performed to confirm
the maximum tolerated dose (MTD), or recommended doses of both BI 836845 and enzalutamide
that can be taken together.
Once the MTD, or recommended phase II dose, have been determined an expansion cohort will
also be explored (phase Ib expansion) in CRPC patients already taking enzalutamide and have a
rise in prostate serum antigen (PSA) levels. Patients may not have received prior docetaxel
or abiraterone. Patients in this cohort will receive the MTD, or recommended phase II dose,
of BI 836845 and enzalutamide determined in the phase Ib escalation phase.
The randomised trial (phase II) will be an open label, parallel group study design in a 1:1
ratio to which patients will receive either BI 836845 plus enzalutamide (Arm A) at the
MTD/recommended doses, or enzalutamide alone (Arm B).
In all parts of the trial safety, anti-tumour activity will be assessed, in addition to
circulating tumour cells (CTC), prostate serum antigen (PSA) response and progression, and
determination of Overall Survival (OS).